On April 2, 2019 the FDA further described its upcoming effort to regulate or at least discuss the regulation of cannabis-containing and cannabis-derived products. The FDA reiterated its power as given to it by the 2018 Farm Bill to regulate cannabis products and to ensure that they are used and sold safely in drugs, dietary supplements and conventional food.
The FDA had previously announced its intention to have a public hearing on May 31, 2019. FDA is seeking information in advance of the public hearing regarding risks from use of CBD and other cannabis-derived products, including information about whether there is “some threshold level of CBD that should be allowed in conventional foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.” The FDA wants to consider a path of regulation that would fulfill all the requirements of the food additive and dietary ingredient regulations.
FDA is seeking comments on a variety of topics including “what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g. common ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; and how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients.”
The FDA seems to be exploring a dual track of drug approval and non-drug commercial availability and is seeking this information to see if such a regulatory structure is possible.
Finally, FDA reiterated its concerns, and intention to enforce rules, related to unsubstantiated health claims such as “CBD’s successfully stopped cancer cells and multiple different cervical cancer varieties.” Unsubstantiated health claims will still draw FDA action regardless of the mode of delivery.